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UK Blood, Tissues and Cells: EU harmonisation in the works

In June, the European Commission adopted the proposal for a regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application. This proposed regulation will repeal the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) and introduce a new European regulatory framework in line with the significant technological advances in this field.

On 28 September 2022, the Department for Health and Social Care (DHSC) published a policy paper on the proposed regulation. The paper considers the impact of this regulatory change on Northern Ireland (NI), as when it's introduced the regulation will have direct effect in NI. DHSC acknowledge that the intention of the proposed regulation is to increase the safety, quality, innovation and supply of SoHO within the EU, and therefore the regulation is likely to have a positive effect in NI. However, the paper also discusses the consequences of regulatory divergence between NI and Great Britain (GB), which could include supply chain disruption since NI is reliant on importing SoHO from GB.

It is clear from the paper that the UK government will act to harmonise some aspects of the UK framework with that of the proposed EU regulation. In particular, the paper notes that it will be important to maintain minimum standards with the EU to allow the movement of NI and EU SoHO into the UK. DHSC expects to conduct a targeted stakeholder consultation (but not a public consultation) to inform policy decisions.

Overall, this paper suggests that overarching harmonisation between the UK and EU life sciences regulatory frameworks is a theme that will continue.

It will be important to maintain minimum standards with the EU to allow the movement of NI and EU SoHO which is used in life-saving and life-changing treatments for patients across the UK.


life sciences, life sciences regulatory, brexit